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Completed

NCT Number: NCT02894125

Evaluation of the Effectiveness of a SPA Therapy to "Neyrac-les-Bains" to the Old Subject (60-80 Years Old) With a Chronic Low Back Pain.

Low back pain is considered to be chronic if it has been present for longer than three months.

This pathology is extremely frequent with an annual incidence between 5 in 10 % of the general population. Thus she is frequently met in general medicine, in particular to the ageing subject. It is the 2nd motive for consultation.

The Chronic Low Back Pain is a mild pathology the forecast of which is in the favorable great majority of the cases but she pulled a socioeconomic cost mattering with a poly-consumption of care, in private individuals.

The primary objective of this study is to determine the impact of a 3 months SPA Therapy on the Chronic Low Back Pain in older adults (from 60 to 80 years old) realizing a SPA Therapy of 3 weeks to "Neyrac-les-Bains".

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Key information

Conditions

Chronic Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

Realization of the protocol :

  • Selection of the patients (realized during the consultation of programming in the beginning of the SPA Therapy). They are 2 thermal doctors of "Neyrac-les-Bains" (1 general practitioner with formation of thermal medicine and a rheumatologist) which include the eligible patients in this study during the visit of the beginning of SPA Therapy.
  • They will put back to the patients the Inform Consent Form, the Form of non-opposition and the 1st questionnaire (J0). The nurse of the SPA Therapy will be at their disposal to help them to fill the questionnaire if need.

An urn will be arranged in the entrance hall of Neyrac- les-Bains to get back the filled questionnaires (J0 and J21).

Patients will follow the conventional SPA Therapy of 3 weeks without a specific changes or modification of the care provided.

Feedback :

Assessments conducted by the using of self - questionnaires:

  • Delivered in the issue of the visit of inclusion and at the end of the Spa Therapy ;
  • Sent by mail at 3 and 6 months

The expectations and fears will be evaluated by means of individual interview or focus groups. To avoid the biases bound to the questionnaire, the patients questioned in qualitative are different from patients receiving the questionnaire (not over the same period of SPA Therapy).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - Both sexes
  • 60-80 years old
  • Realizing a SPA Therapy of 3 weeks.
  • Presenting a mechanical pain of the rachis lumbar vertebra > 3 months
  • Possible irradiation up to the knee (cruralgia / sciatalgie truncated)
  • Cooperation and understanding allowing to conform in a strict way to the conditions planned by the study
  • Acceptance to participate in the study (non-opposition)

Exclusion criteria

  • - < 60-year-old patients or > 80 years
  • Inflammatory, tumoral, traumatic or infectious rheumatism
  • Surgery of the back
  • SPA Therapy dating less than 6 months
  • Evolutionary slipped disc
  • Disorders(confusions) of the concentration or the compression of the written or oral French language making impossible the realization of the study
  • The pain estimated by the digital scale = 0 in the inclusion

Treatment and study plan

Spa therapy

Other

Primary outcomes

  1. Pain's estimation by the digital scale

    Time frame: at 3 months

Secondary outcomes

  1. functional incapacity by means of the questionnaire "Oswestry Disability index"

    Time frame: at 0 days, 21 days, 3 months and 6 months

  2. personal efficacy by means of the French questionnaire ASES "Arthritis Self Efficacy Scale"

    Time frame: at 0 day , 21 days, 3 months, 6 months

  3. fears and the faiths with the FABQ (physical dimension only)

    Time frame: at 0 day , 21 days, 3 months, 6 months

  4. consumption of analgesic estimated by a standardized collection

    Time frame: at 21 days, 3 months, 6 months

  5. expectations and fears by means of individual interview or focus groups by means of the quantitative questionnaire for qualitative analysis.

    Time frame: at 0 day

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2016
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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